Antiemetics known to prolong the QT interval including dolasetron and ondansetron may be used with frequent ECG monitoring.

Drug-Food:

↑ blood levels and risk of toxicity with foods that are CYP3A inhibitors including grapefruit/grapefruit juice, pomegranate/pomegranate juice and star fruit; avoid these foods.

Route/Dosage

PO (Adults): 20 mg every other day for 3 doses every wk (days 1, 3, 5, 8, 10 and 12) for 2 wk of every 21–day cycle for 8 cycles; an additional 8 cycles may be added if there is clinical benefit without dangerous toxicity. Given concurrently with bortezomib and dexamethasone. Dose reduction/interruption/alteration/discontinuation may be required for gastrointestinal or hematologic toxicity. Concurrent use of strong CYP3A4 inhibitors– ↓ starting dose to 10 mg.Hepatic Impairment PO (Adults): Mild hepatic impairment– ↓ starting dose to 15 mg, Moderate hepatic impairment– ↓ starting dose to 10 mg.

Availability

Capsules: 10 mg, 15 mg, 20 mg

Assessment

Monitor for diarrhea during therapy. At first sign of abdominal cramping, loose stools, or onset of diarrhea, medicate patient with antidiarrheals (loperamide). Assess and maintain hydration status. If patient has moderate diarrhea (4–6 stools/day), interrupt panobinostat until diarrhea is resolved, then restart at same dose. If patient has severe diarrhea (≥7 stools/day) and IV fluids or hospitalization is required, interrupt panobinostat until diarrhea is resolved, then restart at reduced dose. If life-threatening diarrhea occurs, permanently discontinue panobinostat.

Obtain ECG prior to and periodically during therapy as clinically indicated. QTcF must be <450 msec before starting therapy. Interrupt therapy if QTcF increases ≥480 msec. Correct any abnormal electrolyte levels. Discontinue panobinostat if QT prolongation does not resolve.

Monitor for nausea and vomiting. Consider administering prophylactic anti-emetics. If patient has severe nausea, interrupt panobinostat until nausea is resolved and restart at reduced dose. If severe, life-threatening vomiting occurs, interrupt panobinostat until vomiting is resolved and restart at reduced dose.

PO Administer at same time each scheduled day without regard to food, with a whole cup of water. Swallow capsules whole; do not open, crush, or chew. If patient vomits, do not repeat dose but take next usual scheduled dose.

Patient/Family Teaching

Instruct patient to take panobinostat as directed. Take missed dose as soon as possible within 12 hrs or wait until next scheduled dose. If vomiting occurs, do not repeat dose, take next dose at scheduled time. Advise patient to read Medication Guide prior to starting and with each Rx refill in case of changes.

Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications during therapy.

Rep: Caution female patient that panobinostat is teratogenic. Use effective contraception during and for at least 3 mo after therapy and avoid breastfeeding. Advise male patient to use condoms during and for at least 6 mo after last dose of panobinostat. Advise patient to notify health care professional if pregnancy occurs during therapy.

Emphasize the need for lab tests periodically during therapy to monitor for adverse reactions.